EndoSurofICH: Comparison Between Stereotactic Aspiration and Intra-endoscopic Surgery to Treat Intracerebral Hemorrhage

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02515903

Collaborator

Shenzhen People's Hospital (Other)

100

Enrollment

Location

Arms

18.1

Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Views for surgery method selection of intracerebral hemorrhage are still controversial. Since the application of neuroendoscopic technique in intraventricular hemorrhage was confirmed effective and safe, some investigators have attempted to use endoscopic strategies to evacuate intracerebral hematomas. Some significant advances have also been reported in endoscopic hematoma evacuation when compared to conventional craniotomy. However, it is still crucial to implement a prospective and controlled study to evaluate the efficiency and safety of endoscopic technique in the treatment of intracerebral hemorrhage. In this study, the investigators will exclusively select some patients with intracerebral hemorrhage in the basal ganglia region. This study will compare the efficacy and safety of endoscopic surgery versus stereotactic aspiration on neurologic outcomes for patients with intracerebral hemorrhage.

Condition or Disease	Intervention/Treatment	Phase
Intracerebral Hemorrhage Surgery	Procedure: Intra-endoscopic surgery Procedure: Placebo:stereotactic aspiration surgery	N/A

Detailed Description

Although the incidence and mortality of spontaneous intracerebral hemorrhage (ICH) have been decreased with the improved management of high blood pressure, ICH may induce serious disability for the patients and continue to be a major socioeconomic problem. The evacuation of ICH using open craniotomy or computer tomography (CT)-guided stereotaxy may improve the survival rate of these patients but failed to prove efficacy in improving patients' functional outcome despite numerous efforts. Endoscopy-guided evacuation of ICH provides a less invasive and quicker surgical decompression, which may potentially improve the functional outcome for patients. In previous studies, endoscope-guided evacuation of ICH is often referred to as that an endoscope only provides an illuminating system while the operating channel is independent from the endoscope (endoscopy-controlled microneurosurgery or endoscopy-assisted microneurosurgery). In recent years, authors have been committed to explore the procedure of intra-endoscopy-guided evacuation of ICH, which means that the illuminating channel, the irrigation-aspiration channel and the working channel are all located in the endoscope. This kind of procedure can be called as real endoscopic neurosurgery (EN), which may potentially decrease the operative concomitant injuries at the most extent. However, the inherent drawbacks of intra-endoscopic procedures, including the limited visualization of the surgical field and the difficult maintenance of patency of the aspiration wand, can offset the advantages in some instances. The authors exclusively invented a special endoscopic transparent sheath for guiding hematoma puncture and an agitation-aspiration system (AAS) for keeping patency of the aspiration wand. Detailed procedures of their application will be implemented and verified in a series of patients with intracerebral hemorrhage. Meanwhile, the mortality rate, complications and other outcome parameters between this procedure and CT-guided procedures will be compared.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparison Between Stereotactic Aspiration and Intra-endoscopic Surgery to Treat Intracerebral Hemorrhage

Study Start Date :

May 1, 2015

Anticipated Primary Completion Date :

May 1, 2016

Anticipated Study Completion Date :

Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intra-endoscopy This intervention arm will receive intra-endoscopic evacuation surgery for ICH.	Procedure: Intra-endoscopic surgery Intra-endoscopic surgery for evacuation of ICH
Placebo Comparator: Stereotactic Aspiration This arm will receive stereotactic aspiration surgery for ICH evacuation.	Procedure: Placebo:stereotactic aspiration surgery Placebo:stereotactic aspiration surgery for evacuation of ICH

Arm

Intervention/Treatment

Experimental: Intra-endoscopy

This intervention arm will receive intra-endoscopic evacuation surgery for ICH.

Procedure: Intra-endoscopic surgery

Intra-endoscopic surgery for evacuation of ICH

Placebo Comparator: Stereotactic Aspiration

This arm will receive stereotactic aspiration surgery for ICH evacuation.

Procedure: Placebo:stereotactic aspiration surgery

Placebo:stereotactic aspiration surgery for evacuation of ICH

Outcome Measures

Primary Outcome Measures

Mortality rate [90-day]
all-cause motality rate within 90 days after the surgery

Secondary Outcome Measures

operative time [24 h]
the period from skin incision to wound suture
days of ICU stay [14 day]
the period between the end of the surgery to leaving the ICU
remnant blood in the hematoma after surgery [12 hour]
this parameter will be monitored by CT scan immediately after the surgery
Glasgow coma score [28 day]
the GCS will be evaluated by a senior doctor 28 days after the surgery
Glasgow outcome score [90-day]
the GCS will be evaluated by a senior doctor 28 days after the surgery
In-hospital cost [28 day]
all medical cost during the in-hospital period
rehemorrhage rate [3 day]
Rehemorrhage almost occurs within 3 days after the surger. So cranial CT scan will be performed routinely 3 days later after surgery to evaluate the rehemorrhage rate
intracranial infection [14 day]
If the patient underwent a period of fever, cerebral fluid will be withdrawn by means of lumbar puncture and tested to verify whether the intracranial infection occurs